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The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged 6-17
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD503 (Guanfacine HCl) (2 mg) | Experimental |
| |
| SPD503 (3 mg) | Experimental |
| |
| SPD503 (4 mg) | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD503 (Guanfacine hydrochloride) (2 mg) | Drug |
| ||
| SPD503 (3 mg) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks | Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. | Baseline and up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks | The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18166547 | Result | Biederman J, Melmed RD, Patel A, McBurnett K, Konow J, Lyne A, Scherer N; SPD503 Study Group. A randomized, double-blind, placebo-controlled study of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. Pediatrics. 2008 Jan;121(1):e73-84. doi: 10.1542/peds.2006-3695. |
| Label | URL |
|---|---|
| FDA recall information | View source |
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Subjects were randomized to receive either 2, 3, or 4 mg SPD503 (Guanfacine hydrochloride) or placebo once-daily.
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| ID | Title | Description |
|---|---|---|
| FG000 | SPD503 2mg | Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily. |
| FG001 | SPD503 3mg | Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily. |
| FG002 | SPD503 4mg | Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily. |
| FG003 | Placebo | Subjects were randomized to receive Placebo once-daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPD503 2mg | Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily. |
| BG001 | SPD503 3mg | Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks | Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. | Intent to treat (ITT) defined as all subjects who were randomized to treatment and had the baseline and at least one post-randomization primary efficacy measurement. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline and up to 5 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPD503 2mg | Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D016316 | Guanfacine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
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| Drug |
|
| SPD503 (4 mg) | Drug |
|
| Placebo | Drug |
|
| Baseline and up to 5 weeks |
| Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks | The Conner's Teacher Rating Scale-revised short version (CTRS-R) consists of 28 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 84. Higher scores are indicative of increased ADHD. This scale allows teachers to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. | Baseline and up to 5 weeks |
| Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) | Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. | up to 5 weeks |
| Number of Participants With Improvement in Parent Global Assessment (PGA) | Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. | up to 5 weeks |
| Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks | The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. | Baseline and 5 weeks |
| FDA-approved label | View source |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| ECG abnormalities |
|
| Sponsor's decision |
|
| BG002 | SPD503 4mg | Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily. |
| BG003 | Placebo | Subjects were randomized to receive Placebo once-daily. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| SPD503 3mg |
Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily. |
| OG002 | SPD503 4mg | Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily. |
| OG003 | Placebo | Subjects were randomized to receive Placebo once-daily. |
|
|
|
| Secondary | Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks | The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. | ITT | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline and up to 5 weeks |
|
|
|
|
| Secondary | Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks | The Conner's Teacher Rating Scale-revised short version (CTRS-R) consists of 28 questions graded on a scale from 0 (not true at all) reflecting no symptoms to 3 (very much true) reflecting severe symptoms with a total score ranging from 0 to 84. Higher scores are indicative of increased ADHD. This scale allows teachers to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior. | ITT | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline and up to 5 weeks |
|
|
|
|
| Secondary | Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) | Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. | ITT | Posted | Number | Participants | up to 5 weeks |
|
|
|
|
| Secondary | Number of Participants With Improvement in Parent Global Assessment (PGA) | Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. | ITT | Posted | Number | Participants | up to 5 weeks |
|
|
|
|
| Secondary | Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks | The Child Health Questionnaire-Parent Form (CHQ-PF50) was developed to measure the physical and psychosocial well-being of children aged 5 years of age and older. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. | ITT | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline and 5 weeks |
|
|
|
|
| 0 |
| 87 |
| 67 |
| 87 |
| EG001 | SPD503 3mg | Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily. | 1 | 86 | 76 | 86 |
| EG002 | SPD503 4mg | Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily. | 1 | 86 | 75 | 86 |
| EG003 | Placebo | Subjects were randomized to receive Placebo once-daily. | 0 | 86 | 55 | 86 |
| Asthma aggravated | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Lethargy | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Appetite decreased | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Sedation | Nervous system disorders | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates. |
| 0.035 |
| 95 |
| Superiority or Other (legacy) |
| ANCOVA | Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates. | <0.0001 | 95 | Superiority or Other (legacy) |
Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates. |
| <0.0001 |
| 95 |
| Superiority or Other (legacy) |
| ANCOVA | Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates. | <0.0001 | 95 | Superiority or Other (legacy) |
| 95 |
| Superiority or Other (legacy) |
| Cochran-Mantel-Haenszel | 0.0001 | 95 | Superiority or Other (legacy) |
| 95 |
| Superiority or Other (legacy) |
| Cochran-Mantel-Haenszel | <0.0001 | 95 | Superiority or Other (legacy) |
| Physical |
|
Psychosocial category
| ANCOVA |
Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates. |
| 0.1426 |
| 95 |
| Superiority or Other (legacy) |
| Psychosocial category | ANCOVA | Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates. | 0.0191 | 95 | Superiority or Other (legacy) |